SOP Development Package: Food Processing Operations & Raw Material Control
Regulatory Basis: 21 CFR §117.80 (Processes and Controls)
Scope of Work
Development of customized SOPs and records covering:
A. Manufacturing, Processing, Packing, and Holding Activities
- • Sanitation principles for general operations (receiving, inspecting, transporting, segregating)
- • Quality control protocols to ensure food suitability
- • Allergen control and contamination prevention measures
- • Corrective handling of contaminated or adulterated products
- • Oversight responsibilities for sanitation management
- • Testing protocols (chemical, microbial, extraneous material)
B. Handling of Raw Materials and Ingredients
- • Incoming inspection and segregation SOP
- • Allergen management (including identification and labeling of allergenic ingredients or rework)
- • Washing/sanitizing methods and water quality control
- • Storage practices (e.g., temperature, humidity, bulk holding)
- • Contaminant control (e.g., aflatoxin, pests, natural toxins)
- • SOP for thawing and reconditioning
- • Compliance with defect action levels and FDA limits
Deliverables
| Component | Description |
|---|---|
| ✅ SOP: General Manufacturing & Processing Operations | Includes sanitation, allergen, and contamination control |
| ✅ SOP: Quality Control & Oversight | Defined roles for personnel assigned to sanitation functions |
| ✅ SOP: Raw Material Receiving & Inspection | Cleanliness checks and segregation criteria |
| ✅ SOP: Rework & Allergen Ingredient Management | Labeling, storage, and traceability protocols |
| ✅ SOP: Washing, Thawing & Holding Procedures | With water quality and time-temperature control |
| ✅ SOP: Non-Conformance Handling | Rejection or treatment of adulterated food |
| ✅ Logs: Ingredient Inspection, Rework Tracking, Testing Records | Editable and traceable |
| ✅ Training Guide + Staff Quiz | Compliance-based materials for onboarding |
| ✅ CFR Reference Sheet | 117.80 section summary for internal audits |
Fees and Subscriptions
Base SOP Package
Includes 1 process flow + 1 ingredient category + 1 area → $595
Add-On Modules (Customizable):
| Add-On | Description | Price |
|---|---|---|
| 🏭 Additional Processing Equipment SOP | Blenders, slicers, kettles, mixers, etc. | $150/equipment |
| 📦 Additional Operational Area SOP | Receiving, QA room, dry/cold/frozen storage, etc. | $125/area |
| 🌾 Additional Ingredient Type SOP | Allergen-specific, frozen, bulk liquid, etc. | $100/type |
| 🧪 Testing Program SOP | Microbial, chemical, aflatoxin, extraneous material | $200 |
| 📚 Training Deck & Quiz | Visuals, policies, and validation questions | $200 |
| 🧑🏫 Virtual Training Session | 60 mins with sanitation & QC team | $250 |
Sample Packages
| Package | Inclusions | Price |
|---|---|---|
| Starter | Base + 2 equipment + 1 area | $895 |
| Operational Control | Base + 3 ingredients + 2 areas + Training Deck | $1,300 |
| Comprehensive | Base + 5 equipment + 3 ingredients + 3 areas + Virtual Session | $2,150 |
Optional Services
- • Annual SOP Review & Revisions – $375/year
- • Translation (Spanish, French, etc.) – $175/language
- • Virtual Mock Audit of §117.80 Practices – $850/day